Study Completed

Erythema

Bayer Identifier:

12039

ClinicalTrials.gov Identifier:

NCT00839462

EudraCT Number:

Not Available

EU CT Number:

Not Available

Efficacy of Dexpanthenol in thermic erythema

Trial purpose

The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

Inclusion Criteria
- Healthy subjects
- Phototype: I to IV according to Fitzpatrick scale
Exclusion Criteria
- Pregnant or nursing women
- Subjects registered as being in exclusion period in the French Health Minister file of subjects
- Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Trial summary

Enrollment Goal

Trial Dates

September 2007 - September 2007

Phase

Phase 2

Could I Receive a placebo

Products

Dexpanthenol (BAY81-2996)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		VILLEURBANNE, 69100, France

Primary Outcome

Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
Time Frame:
2 min, 5 min, 10 min, 15 min
Safety Issue:
yes

Secondary Outcome

Skin temperature
Time Frame:
2 min, 5 min, 10 min
Safety Issue:
no
Evaluation of the cooling/soothing effect (scores) after first and second application
Time Frame:
2 min, 5min, 10 min, 15 min
Safety Issue:
no
Evaluation of the foam covering properties after first application
Time Frame:
2 min, 5 min, 10 min, 15 min
Safety Issue:
no
Incidence of adverse events
Time Frame:
FPFV - LPLV
Safety Issue:
yes

Trial design

Evaluation of the effect of Bepanthen burn relief foam spray new formula on a thermic erythema. Equivalence trial. Intra-individual design.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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